Track­ing a suc­cess­ful DL­B­CL as­sault in Phase II, Mor­phoSys sets out to seize quick OK for MOR208

En­cour­aged by a break­through des­ig­na­tion at the FDA and its lat­est batch of up­beat da­ta from a Phase II study of its an­ti-CD19 an­ti­body MOR208, Mor­phoSys says it’s blaz­ing a straight path to reg­u­la­tors in search of an ac­cel­er­at­ed ap­proval.

Mor­phoSys ex­ecs spent a good deal of time talk­ing to an­a­lysts yes­ter­day about their rea­sons for shoot­ing at a quick OK. The Ger­man biotech high­light­ed up­dat­ed da­ta demon­strat­ing that of the 68 evalu­able pa­tients in their study for dif­fuse large B cell lym­phoma — a pop­u­lar dis­ease tar­get in on­col­o­gy — they tracked a 49% over­all re­sponse rate and a 31% com­plete re­sponse rate.

They al­so have a pre­lim­i­nary pro­gres­sion free sur­vival rate of 50.5% at 12 months.

Malte Pe­ters

This is a sin­gle arm study of the Mor­phoSys an­ti­body com­bined with lenalido­mide for 81 DL­B­CL pa­tients not el­i­gi­ble for high-dose chemo or au­tol­o­gous stem cell trans­plan­ta­tion. And it says a lot about why biotechs are bar­rel­ing in­to can­cer with high ex­pec­ta­tions of break­ing new ground ear­li­er than ever.

Malte Pe­ters, the chief de­vel­op­ment of­fi­cer at Mor­phoSys, spelled it out for an­a­lysts:

Specif­i­cal­ly 29 out of 33 pa­tients which have re­spond­ed, that amount to 88% are on­go­ing, 20 of whom have an on­go­ing com­plete re­sponse. The mean time to re­spond was short with 1.8 months and the mean time to ex­pe­ri­ence a com­plete re­sponse was 3.6 months….

At this time, we are hop­ing to be able to sub­mit da­ta from the cur­rent L-MIND tri­al to the FDA as a ba­sis for reg­u­la­to­ry ap­proval. Our goal is to achieve an ac­cel­er­at­ed ap­proval based pri­mar­i­ly on the L-MIND study. Apart from L-MIND, we are cur­rent­ly in­ves­ti­gat­ing MOR208 in the same pa­tient pop­u­la­tion in our Phase III B-MIND tri­al. This is a head-to-head study in­ves­ti­gat­ing the ef­fi­ca­cy of MOR208 plus ben­damus­tine ver­sus rit­ux­imab plus ben­damus­tine. Rit­ux­imab plus ben­damus­tine is one of the most com­mon­ly used reg­i­mens in the re­lapse re­frac­to­ry DL­B­CL set­ting.

The FDA al­ready has this drug down in the spe­cial BTD path based on an ear­li­er snap­shot of da­ta from the same study. That gives Mor­phoSys a rea­son­able hope that it can move fast to­ward a fil­ing while lin­ing up the big­ger Phase III as a con­fir­ma­to­ry study.

Si­mon Mo­roney

At this point, the ac­cel­er­at­ed ap­proval path­way has been blazed by a mob of de­vel­op­ers who need­ed to show that they were do­ing a rea­son­able per­cent­age of late-stage pa­tients some good. The FDA has re­spond­ed with alacrity, and reg­u­la­tors in the US are on­ly pick­ing up even more speed un­der the di­rec­tion of FDA com­mis­sion­er Scott Got­tlieb. Mor­phoSys – al­lied with a group of A-list part­ners on oth­er drugs – has good rea­son to be­lieve that they can take the same short cut.

Not­ed CEO Si­mon Mo­roney:

“We are very en­cour­aged by our most re­cent clin­i­cal da­ta from the on­go­ing L-MIND tri­al, which sup­port our plan to de­vel­op MOR208 in com­bi­na­tion with lenalido­mide as a chemo-free treat­ment op­tion for this pa­tient pop­u­la­tion.”

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,400+ biopharma pros reading Endpoints daily — and it's free.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.